Pain Due to Certain Specified ProceduresPhase 2/3FENTANCT02298582
Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly
A Phase 2/3 study testing intranasal fentanyl in people with Pain Due to Certain Specified Procedures, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain induced by wound care and rehabilitation in the elderly. The project would also provide a preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Pain Due to Certain Specified Procedures
- What is being tested?
- intranasal fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2014to Apr 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized geriatric patient requiring care or rehabilitation
- Patient with pain during treatment or mobilization. (VAS ≥ 4)
- Written Informed consent
Who cannot join
- All unstable fractures
- Confusion: unable to assess their level of pain using a VAS.
- Contraindications to PecFent ® (. Hypersensitivity to the active substance or to any of the excipients listed in section Composition Use in patients who had never received treatment for opioid severe respiratory depression or severe obstructive pulmonary disease.)
- Person under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly With or Without Background Treatment.
The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain induced by wound care and rehabilitation in the elderly. The project would also provide a preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.
Read the detailed description
This is a safety clinical trial. This trial is monocentric, open label, non-randomized.
Sixty elderly patients will be enrolled in this study, 30 with bedsore cares and 30 with rehabilitation sessions.
Six bedsore cares or rehabilitation sessions will be assessed for each subject. For each session, patient pain will be evaluated using a visual analogic scale VAS at different times, before session, 5 minutes then 20 minutes after the beginning of the session, and a last VAS 1 hour after the end of the session. During the two first sessions, patients do not receive Pecfent® to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care.
An evaluation of respiratory rate and of the level of sedation will occur at different time : after 5 minutes then 20 minutes of care, at the end of the care session,at half an hour then one hour after the care session.
At the end of sessions,
- The nurse or physiotherapist will assess their satisfaction regarding the objectives achieved during the session with a four points verbal descriptor scale (very satisfied, satisfied, not much satisfied, not satisfied). They will also evaluate at the end of the four last session their satisfaction regarding the convenience of the use of pecfent® and its contribution towards care.
- Patients will assess their satisfaction regarding the course of the session with a verbal descriptor scale (VDS) and their level of anxiety felt during the session with a VAS.
- Conditions
- Pain Due to Certain Specified Procedures
- Being tested
- intranasal fentanyl
- Keywords
- safety, procedural pain, intranasal fentanyl, elderly
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal fentanylDrug
During the two first sessions of care or rehabilitation, patients do not receive Pecfent® in order to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care. A titration of PecFent will be done at each session
| Study group | Role | What they receive |
|---|---|---|
| Intranasal fentanyl | Experimental | Not described Receives: Drug: intranasal fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects.
The nature and frequency of adverse effects will be described. The collection of adverse events will be first, with the collection of spontaneous patient complaints from nurses on the other hand, by systematic screening with the patient. Monitoring of respiratory rate and level of sedation will also be set up.
Measured: 5 days after the last intake of fentanyl.
Secondary outcomes (4)
Effectiveness of intranasal fentanyl in procedural pain using a VAS (Visual Analogic Scale) of pain.
VAS will be evaluated during each session at t0, t0+15min, t0+30min, and 1hour after the session (on average at 2 hours)
Measured: Evolution of the level of pain (VAS) since the beginning of care until one hour after the end of session (on average at 2 hours).
Fentanyl impact on the goals of care as measured by a caregiver satisfaction scale.
At the end of each session of care or rehabilitation, it will be proposed to the caregiver, a scale measuring its satisfaction regarding the objectives achieved during the session.
Measured: At the end of session of care or rehabilitation (on average at 1 hour).
Nurse or physiotherapist satisfaction regarding use of PecFent® as measured by a verbal descriptor scale
Nurse or physiotherapist evaluation satisfaction regarding the convenience of the use of pecfent® and its contribution towards care using a verbal descriptor scale
Measured: 1 hour after the last intake of fentanyl
Impact of PecFent® on patient feelings during care or rehabilitation sessions as measured by a verbal descriptor scale
Patient evaluation at the end of sessions:
- Patient satisfaction regarding the course of the session with a VDS
Measured: At the end of Session of care or rehabilitation (on average at 1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start8 Dec 2014
- Primary completion24 Oct 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Due to Certain Specified ProceduresStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298582
- Sponsor's protocol ID
- DCIC/13/67
- Acronym
- FENTA
- Status last verified
- May 2018
- First submitted
- 13 Oct 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly With or Without Background Treatment.
- ClinicalTrials.gov ID
- NCT02298582
- Acronym / sponsor ID
- FENTA / DCIC/13/67
- Conditions
- Pain Due to Certain Specified Procedures
- Keywords
- safety, procedural pain, intranasal fentanyl, elderly
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain induced by wound care and rehabilitation in the elderly. The project would also provide a preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.
Detailed description
This is a safety clinical trial. This trial is monocentric, open label, non-randomized.
Sixty elderly patients will be enrolled in this study, 30 with bedsore cares and 30 with rehabilitation sessions.
Six bedsore cares or rehabilitation sessions will be assessed for each subject. For each session, patient pain will be evaluated using a visual analogic scale VAS at different times, before session, 5 minutes then 20 minutes after the beginning of the session, and a last VAS 1 hour after the end of the session. During the two first sessions, patients do not receive Pecfent® to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care.
An evaluation of respiratory rate and of the level of sedation will occur at different time : after 5 minutes then 20 minutes of care, at the end of the care session,at half an hour then one hour after the care session.
At the end of sessions,
- The nurse or physiotherapist will assess their satisfaction regarding the objectives achieved during the session with a four points verbal descriptor scale (very satisfied, satisfied, not much satisfied, not satisfied). They will also evaluate at the end of the four last session their satisfaction regarding the convenience of the use of pecfent® and its contribution towards care.
- Patients will assess their satisfaction regarding the course of the session with a verbal descriptor scale (VDS) and their level of anxiety felt during the session with a VAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal fentanyl | Experimental | Drug: intranasal fentanyl |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Hospitalized geriatric patient requiring care or rehabilitation
- Patient with pain during treatment or mobilization. (VAS ≥ 4)
- Written Informed consent
Key exclusion criteria (4 listed)
- All unstable fractures
- Confusion: unable to assess their level of pain using a VAS.
- Contraindications to PecFent ® (. Hypersensitivity to the active substance or to any of the excipients listed in section Composition Use in patients who had never received treatment for opioid severe respiratory depression or severe obstructive pulmonary disease.)
- Person under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intranasal fentanylDuring the two first sessions of care or rehabilitation, patients do not receive Pecfent® in order to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care. A titration of PecFent will be done at each session | Drug | Intranasal fentanyl |
Primary outcome
Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects.
Time frame: 5 days after the last intake of fentanyl.
The nature and frequency of adverse effects will be described. The collection of adverse events will be first, with the collection of spontaneous patient complaints from nurses on the other hand, by systematic screening with the patient. Monitoring of respiratory rate and level of sedation will also be set up.
4 secondary outcomes
Effectiveness of intranasal fentanyl in procedural pain using a VAS (Visual Analogic Scale) of pain.
Time frame: Evolution of the level of pain (VAS) since the beginning of care until one hour after the end of session (on average at 2 hours).
Fentanyl impact on the goals of care as measured by a caregiver satisfaction scale.
Time frame: At the end of session of care or rehabilitation (on average at 1 hour).
Nurse or physiotherapist satisfaction regarding use of PecFent® as measured by a verbal descriptor scale
Time frame: 1 hour after the last intake of fentanyl
Impact of PecFent® on patient feelings during care or rehabilitation sessions as measured by a verbal descriptor scale
Time frame: At the end of Session of care or rehabilitation (on average at 1 hour).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intranasal fentanyl in people with Pain Due to Certain Specified Procedures, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects. (time frame: 5 days after the last intake of fentanyl.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.